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Abbott Gains FDA Approval for 'Enhancements' to HIV-1 Test

NEW YORK (GenomeWeb News) - Abbott said Thursday it has received supplemental pre-market approval from the US Food and Drug Administration for improvements to its RealTime HIV-1 viral load test, which runs on its m2000 RT PCR platform.
 
The FDA initially cleared the test in May.
 
Abbott said the supplemental approval will allow it to market “a number of enhancements” for the test, including a feature that will allow labs to use smaller amounts of blood plasma.
 
Abbott markets the m2000 system and its line of tests internationally through an agreement with Celera.
 
The test detects and quantitates common HIV-1 strains, "as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes," the company said.
 
Abbott said the ability to use smaller samples to identify HIV-1 will be useful because of the challenges of obtaining blood samples from critically ill patients.
 
The company said the enhanced system can process up to 96 specimens in a batch and 192 specimens in one laboratory shift, which it said is the "highest throughput available" for an HIV-1 test using RT-PCR technology.
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